international conference on advances in pharmaceutical

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International Conference on Advances in Pharmaceutical Drug Development, Quality Control and Regulatory Sciences DDRS 2021 CALL FOR SPONSORSHIP and EXHIBITION http://ddrs2021.hu/

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International Conference on Advances in

Pharmaceutical Drug Development, Quality

Control and Regulatory Sciences

DDRS 2021

CALL FOR SPONSORSHIP and EXHIBITION

http://ddrs2021.hu/http://ddrs2020.hu/

Invitation Dear Sponsor, Dear Exhibitor,

The corona virus pandemic has disrupted everyone’s life and has brought about significant changes in their normalcy. The Co-Chairs and the Local Organisers of DDRS have been continuously monitoring the epidemic situation caused by the corona virus. Keeping participants’ safety in focus, a survey was conducted among our participants, speakers and sponsors to learn about their preference for this international conference. Overwhelming majority preferred to have a conventional face-to-face conference at a later date. DDRS Conference as a culminating event of a series of conferences in the topic has its merits by having a highly

international faculty and audience and the time to interact and network during the conference. It was also essential that DDRS Conference remain a part of the Semmelweis University 250-year jubilee event series. After taking into consideration all facts, circumstances and eventual consequences, the organisers decided to have this DDRS Conference moved to 15-17 November 2021. By the original date, participants had registered from 48 countries of 5 continents!

As one of Europe’s most prestigious drug research conferences, the International Conference on

Advances in Pharmaceutical Drug Development, Quality Control and Regulatory Sciences (DDRS 2021) will be organised on Margaret Island, Budapest, 15-17 November, 2021 on the occasion of the 250th anniversary of the foundation of Semmelweis University in Budapest, Hungary. The conference is among the top scientific events to be held throughout the jubilee year.

This is a follow-up of a very successful series of (1) International Regulatory Workshops on Bioequivalence, Bioanalysis, Dissolution and Biosimilarity (BEW Series) and (2) International Symposium on Scientific and

Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence (SRACD Series). This conference aims to present a complete gamut of scenarios from drug development, quality control, the regulatory challenges, and the practical use and handling of (complex) drug products for a broad range of dosage forms. The conference will address new trends in pharmaceutical, regulatory science of biological and non-biological complex drugs (NBCDs) and the challenges for their correct use. Keynote addresses will provide different perspectives on where we came from, where we are and where we are

heading to. The conference will also discuss advances in bioanalytical methodologies to characterize these complex drugs with their critical quality attributes and Drug-Device Combination products. Topics will be addressed regarding the bioequivalence evaluation of complex drugs. Experts will highlight COVID-19 vaccine developments and challenges.

Panel Discussions will be held to discuss hot topics with moderators, invited experts, session speakers and the participants. The symposium will also offer ample opportunities for the participants to interact with

international speakers, representatives of CROs and exhibitors.

In order to enhance the participation of young research scientists in the international symposium, posters are welcome and will be presented in an attractive format. The conference also intends to introduce a Poster presentation. Selected posters will be awarded.

The venue of the conference will be Ensana Thermal Hotel Margaret Island, located on the beautiful Margaret Island in Budapest, Hungary, in the green heart of the city, where you can also visit the UNESCO

protected Music Fountain and Water Tower. We wish all participants an enriching stay in the vibrant and charming milieu of Budapest, a World Heritage Protected City since 1987, has enchanted visitors from all over the world as Budapest has recently won the title of “The Best Destination in Europe in 2019” in a public vote organised by the tourism organisation European Best Destination.

The Co-Chairs and the Organising Committee cordially invite you to the DDRS 2021 Conference to Budapest, Hungary. Do not miss the chance to visit our stunning city and attend one of the most advanced scientific

meetings on Pharmaceutical Research and Regulatory Sciences and the cultural programme, the DDRS 2021.

Yours sincerely,

Prof. Imre Klebovich Prof. Vinod P. Shah Prof. Stefan Mühlebach

Co-Chairs of the Conference

Main Scientific Topics of the DDRS 2020

(Invited speakers and poster presentations)

❖ Keynote Speakers: Yesterday – Today – Tomorrow:

⚫ Regulatory perspectives

⚫ Industry perspectives

⚫ Patient/Pharmacy perspectives

❖ New Trends in Pharmaceutical Sciences:

⚫ From small molecules to large molecules and the complex drugs

⚫ Biological complex drugs and Non-biological complex drugs (NBCDs)

⚫ Clinical pharmacology and clinical pharmacy

⚫ Regulatory sciences

❖ Complex Drugs Including Nanomedicines:

⚫ Landscape of complex drugs

⚫ Scientific challenges in biological and non-biological complex drug

⚫ Topicals, inhalations and drugs with special bioequivalence problems

❖ Biologicals and Biosimilars:

⚫ Biosimilars with evolving complexity

⚫ Biosimilars in clinical use: challenges

⚫ Advances in peptides

❖ Regulatory Perspectives:

⚫ FDA: Nanomedicines approval

⚫ EMA: Equivalence approach: non-clinical and clinical aspects

⚫ One global medicine: ICH/WHO: harmonisation of regulatory sciences

⚫ Substitution and interchangeability

❖ (Non-Biological) Complex Drugs and Similars:

⚫ Why NBCDs are special?

⚫ Colloidal (nano-particle) i.v. iron product

⚫ Liposomes

⚫ Challenges in determining and defining bioequivalence

❖ Drug-Device Combination Products:

⚫ Regulatory requirements for drug-device combination products

⚫ The practical consequences of the new Medical Device Directive

❖ Advances in (Bio)Analytical Testing:

⚫ Advances in bioanalytical techniques and LC-MS/MS

⚫ Analytical challenges for complex drug products and characterizing nanoparticle drugs

⚫ Analytical toolbox for proteins: moving to full characterization

⚫ Critical quality attributes: just an analytical challenge?

❖ Advances in Dissolution/Drug Release:

⚫ Dissolution in biorelevant dissolution media

⚫ Drug release from novel dosage forms

⚫ Complexity involved in drug release from nanomedicine: a complex scenario

❖ Aspects of Nanotechnology:

⚫ Nanosimilars and impact on drug selection

⚫ Sustained release nanocrystals and nanofibers in drug delivery

⚫ Nanotechnology, nanobiotechnology in targeted drug delivery

⚫ Nanomedicines in clinical practice: critical aspects to consider

❖ COVID-19 – Opportunities and Challenges of Vaccine Development:

⚫ Advances in new vaccines and peptides

⚫ Academic approach to vaccine development in a global pandemic

❖ Biodegradable Polymers:

⚫ Development, technological, analytical, regulatory and clinical aspects

⚫ New possibilities of biodegradable polymers

❖ Panel Discussion:

⚫ Controversial issues

⚫ Global harmonisation

⚫ Impact of complex drugs on clinical use of drugs

⚫ New possibilities of vaccine development

Congress Venue and Contact Information

The venue of the conference, Ensana Thermal Hotel Margaret Island is uniquely situated on the

quiet and green Margaret Island in the heart of Budapest and offers free use of its large spa area,

an indoor and an outdoor pool, and free WiFi access. The spa area also includes a fitness center,

and various beauty treatments and massages are offered.

Modern, fully renovated and redesigned rooms are waiting for our delegates. Outside the hotel,

guests can take part in various sporting activities (from running and rowing to tennis and cycling),

while the footpaths connecting the historical sites of Margaret Island are perfect for a stroll. You

may not want to return to everyday life after a visit to the island of peace!

In the lecture and exhibition halls the latest audiovisual, WiFi and air-conditioning technologies

will serve the convenience of our participants. Exhibition booths will be located right next to the

coffee break area.

Why it is Worth Sponsoring?

DDRS 2021 Conference provides a range of opportunities advantage of this event to promote your

company among leading scientists dealing with scientific and regulatory advances in complex

drugs coming from academic and institutional background from all around Europe and from

overseas. The Conference also provides an actual international update on hot topics of complex

drugs including bioequivalence, nanotechnology, bioanalytical, COVID-19, etc. (read more at our

Scientific Topics) for companies, CROs active in that market.

We expect

❖ pharmaceutical companies working in the field of small to large molecules

(biotechnological products), original, generic/biosimilars, non-biological complex drugs,

❖ CROs

❖ (bio-)analytical companies of various fields (MS, NMR, etc.)

❖ dissolution and drug release companies

❖ others

We offer a wide range of sponsorship packages as well as supplementary options to achieve the

biggest exposure to your company. We are convinced that this event presents an excellent options

to exhibit your technology and services to a large number of counterparts and, further, to become

a sponsor of this event to make it more attractive. DDRS 2021 Conference will also be an excellent

opportunity to develop effective advertisements that will meet your requirements for high-quality

sponsorship. For advertising, exhibiting and sponsorship opportunities, please contact:

Mr. Attila Varga, CEO

H-1255 Budapest P.O.B. 48., Hungary

Phone: +36 1 225 0210

E-mail: [email protected]

Web: www.diamond-congress.hu

Sponsoring Packages

Below you can read our offers for our graded sponsors and further options for your company.

The sponsoring packages are priced in EUR and all prices are exclusive of VAT.

Diamond

Package

Platinum

Package

Gold

Package

Silver

Package

Number of sponsors limited to 3 5 6 8

Complimentary full conference

registrations 6 3 2 1

Complimentary exhibition stand place 16 m2 8 m2 6 m2 4 m2

Display of company logo in the

main session hall during the breaks as:

Diamond

Sponsor

Platinum

Sponsor

Gold

Sponsor

Silver

Sponsor

Acknowledgement in all conference

publications

Flyer insert in the conference bag up to: 3 flyers or

brochures

2 flyers or

brochures

1 flyer or

brochure

1 flyer or

brochure

Full page colour advertisement on one of

inner pages of the Abstract Book (Acta

Pharmaceutica Hungarica)

- - -

Full page colour advertisement on one of

inner pages of the Final Programme 2 1 1 1

Placement of company logo with link on

the conference website as a:

Diamond

Sponsor

Platinum

Sponsor

Gold

Sponsor

Silver

Sponsor

Brief description of your company profile

with logo in the Final Programme

Placement of a roll-up in the lecture hall

Verbal acknowledgement at the opening

and closing of the conference

25 minutes scientific lecture in the main

programme in the plenary lecture hall - - -

Additional, logo branded benefits for

Diamond Sponsorship

(one option to select)

Exclusive sponsorship of the

- conference smart phone application

- conference concert

- delegate bag

- delegate lanyards and badges

- - -

Cost: 15,000 EUR

+VAT

7,500 EUR

+VAT

5,500 EUR

+VAT

3,500 EUR

+VAT

Additional Sponsoring Opportunities

Exclusive Sponsorship of the Welcome Reception

❖ Available for 1 company

❖ Acknowledgement in all conference materials

❖ Acknowledgement on roll-ups (max. 2 pieces) at the reception area

(roll-up should be provided by the Sponsor)

❖ Company logo on the invitation cards

❖ Placement of company logo on the conference website

Commercial Rate: 3000 EUR+VAT

Exclusive Sponsorship of Conference Banquet Dinner

❖ Available for 1 company

❖ Acknowledgement in all conference materials

❖ Acknowledgement on roll-ups (max. 2 pieces) at the dinner area

(roll-up should be provided by the Sponsor)

❖ Company logo on the invitation cards

❖ Placement of company logo on the conference website

Commercial Rate: 3000 EUR+VAT

Sponsorship of Lunches

❖ Available for 3 companies – one lunch to select

❖ Acknowledgement in all conference materials

❖ Acknowledgement on roll-ups (max. 2 pieces) at the lunch area on the selected day

(roll-up should be provided by the Sponsor)

Commercial Rate: 2500 EUR+VAT / lunch

Exclusive Sponsorship of the Concert

❖ Available for 1 company

❖ Acknowledgement in all conference materials

❖ Company logo on the invitation cards

❖ Placement of company logo on the conference website

Commercial Rate: 3000 EUR+VAT

(if not selected by a Diamond Sponsor)

Sponsorship of Coffee Break

❖ Available for 6 companies – one break to select

❖ Acknowledgement in all conference materials

❖ Acknowledgement on signage prominently displayed at the coffee break area during the

selected coffee break

Commercial Rate: 1500 EUR+VAT / coffee break

Exclusive Sponsorship of Delegates’ Bag

❖ Available for 1 company

❖ The sponsor name / logo printed on the outside front cover of each bag

❖ Acknowledgement in all conference materials

❖ Option to include one promotional flyer in the delegate bags

Commercial Rate: 3000 EUR+VAT

(if not selected by a Diamond Sponsor)

Exclusive Sponsorship of Delegate Notepaper and Pens

❖ Available for 1 company

❖ Sponsor logo printed on the notepad and pens

(notepads and pens should be provided by the sponsor)

❖ Notepaper and pens will be included in the conference bags

❖ Acknowledgement in all conference materials

Commercial Rate: 1500 EUR+VAT

Exhibition and Advertisement Possibilities

As one of the exhibitors at our Conference you have the possibility to present your

company to motivated and well-informed scholars and professionals. If you are interested

in exhibiting, we can offer floor space for your own stand. All prices are exclusive of VAT.

Size and fees for space (width x depth):

4 m2 (2x2 m) 1200 EUR+VAT 6 m2 (3x2 m) 1600 EUR+VAT

The exhibition package fee includes:

❖ net stand area

❖ tables for displaying your company products/services

❖ chairs

❖ waste paper bin

❖ 3 sockets for electricity including energy usage of max 3 kW

❖ 1 complimentary full registration

❖ logo display at the conference webpage

Advertisement packages:

We provide you the possibility to insert advertisements in our Conference’s working

materials. Please note that cover pages of the Final Programme are not available for

advertising (except one page reserved for our Main Sponsor).

Advertisement in the Final Programme

This material will be printed in DIN A5 format

Price for advertising: Inner full page (full colour) 600 EUR+VAT

Flyer insert in the Participants’ Pack

Maximum size: DIN A4 format, the exact quantity will be finalized before the Conference,

depending on the number of applicants.

Price for advertising: Flyers not exceeding 12 pages: 600 EUR+VAT/insert

(company should provide the inserts)

All advertisements should be sent to the Congress Secretariat before September 30, 2021.

Further details and technical parameters are sent upon the order.

Application and General Payment Conditions

All advertisers wishing to apply for any of the services listed in this brochure are required to

register by submitting the enclosed registration form to Diamond Congress Ltd. with an

authorized signature. Application are handled at first-come first-served basis, but priorities are

given to main sponsors, in terms of advertisements, exhibition space, and selection of sponsorship

opportunities. Space will not be reserve without a written application. Exhibition space cannot be

occupied unless the full amount is paid before the dates shown below. The organisers of the

exhibition retain the right to rearrange the stands in case the overall concept or organisational

matters force them to do so. Advertisement will not be printed if the full amount of the advert is

not paid before the deadline indicated. Signing and submitting the application form is binding

agreement, provided exhibition space is available, and considered to be written commitment that

all conditions stated therein are understood and accepted by the applicant.

All prices stated herein exclude VAT which is 27% for Hungarian seated companies. (For

international companies reversed charge VAT applies). Payment should be arranged upon receipt

of our pro forma invoice, according to the following terms.

Payment of sponsorship, fee: September 30, 2021

Cancellation Policy

Cancellation and changes to your orders must be made in writing to the Conference Secretariat.

Refundable amounts and penalties depend on the date of cancellation* and are as follows:

Before October 15, 2021: 50% refunded, 50% retained

After October 15, 2021: no refund

Diamond Congress Ltd. Mr. Attila Varga, CEO

H-1255 Budapest P.O.B. 48., Hungary Phone: +36 1 225 0210

E-mail: [email protected] Web: www.diamond-congress.hu

* and refers only to new orders

Sponsorship and Exhibition Order Form

(Please return this form preferably before September 30, 2021)

Name of the company:

Postal address:

Invoice address (if different from above):

Name of the contact person:

Phone: E-mail:

(EU) VAT Number:

Please tick the appropriate boxes

Sponsorship categories

Diamond Package 15000 EUR+VAT

Platinum Package 7500 EUR+VAT

Gold Package 5500 EUR+VAT

Silver Package 3500 EUR+VAT

Sponsoring Opportunities and Benefits

Sponsorship of the Welcome Reception 3000 EUR+VAT

Sponsorship of Conference Banquet Dinner 3000 EUR+VAT

Sponsorship of the Concert 3000 EUR+VAT

Sponsorship of Lunches 2500 EUR+VAT

Sponsorship of Coffee Break 1500 EUR+VAT

Sponsorship of Delegates’ Bag 3000 EUR+VAT

Sponsorship of Notepapers and Pens 1500 EUR+VAT

Advertisements

Inner page in the Final Programme (full colour) 600 EUR+VAT

Flyer insert (in the conference bag) 600 EUR +VAT/insert

Exhibition

Size of the stand place (width x depth)

4 m2 (2x2 m) 1200 EUR+VAT

6 m2 (3x2 m) 1600 EUR+VAT

Prices and payment conditions

All prices stated above exclude VAT, which is 27 % (as of 2019). Payment should be arranged upon

receipt of our pro forma invoice, according to the following terms:

Deadline of sponsorship and advertisement fees September 30, 2021

Cancellation Policy

Cancellation is not possible from the side of the sponsor, after having sent the expression of intent,

as the service (communication towards the participants) is started by the organisers immediately.

Refundable amounts depend on the date of cancellation and are stated as follows*:

Before September 30, 2021: 50% refunded, 50% retained

After September 30, 2021: no refund

* and refers only to new orders

By signing this application form, I hereby declare that I understood and accepted

the conditions of participation, payment and cancellation.

Date: ……………………..………. Signature: ………………………………………………………………

Please send this form to the Conference Secretariat preferably before September 30, 2021

Diamond Congress Ltd.

Mr. Attila Varga, CEO

H-1255 Budapest P.O.B. 48., Hungary

Phone: +36 1 225 0210

E-mail: [email protected]